Effcacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis: a Multicenter Randomized Controlled Clinical Trial

Phase 4

• Conditions: Chronic Kidney Disease

• Registration Number: ITMCTR2000003199
• Lead Sponsor: Shanghai Sixth People's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged >= 18 years old and <= 70 years old;
2. Patients with chronic kidney disease caused by primary glomerulonephritis diagnosed by previous pathology or diagnosed by clinician;
3. Stage 3b-4 chronic kidney disease, that is, patients with eGFR < 45 and >= 15mL/min/1.73 m2 (2012 KDIGO standard);
4. 24-hour urinary protein quantification < 3g during the screening period;
5. Blood pressure, glucose, lipid and uric acid were measured during the screening period and were all in the following range:
blood pressure: systolic blood pressure <140 and diastolic blood pressure < 90 mmHg;
fasting blood-glucose < 8.0mmol/L or HbA1c < 8.0%;
LDLl-c < 100 mg /dl (2.59 mmol/L), and TC < 230 mg /dl (5.95 mmol/L);
uric acid < 420 mol/L;
6. Patients who have signed the informed consent.

Exclusion Criteria

1. Pregnant and lactating women, and women of reproductive age who are unwilling to take reliable contraceptive measures;
2. Patients with known allergy to Jinshuibao;
3. Natural cordyceps sinensis, artificial cordyceps sinensis, traditional Chinese medicine or proprietary Chinese medicine with known renal impairment were used in two weeks before enrollment;
4. Patients who received glucocorticoids, immunosuppressants or tripterygium wilfordii preparations 3 months prior to enrol, or patients who have been confirmed to receive glucocorticoids, immunosuppressants or tripterygium wilfordii preparations;
5. Patients with gastrointestinal impairment or gastrointestinal diseases which may significantly affect the absorption of the experimental drugs, such as confirmed active ulcer (Forrest grade II and below), inflammatory bowel disease, malabsorption syndrome, uncontrollable diarrhea and gastrointestinal surgery;
6. With a history of organ transplant, including kidney transplant;
7. With severe diseases of the heart, brain, liver and hematopoietic system or other serious diseases affecting survival: for example, patients with known malignant tumors, myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack occurred within 6 months;
8. For patients whose disease progresses too rapidly as judged by the clinician, such as eGFR decreases by more than 5ml/min/1.73m2 in the previous year;
9. Patients who participated in other clinical trials within 3 months;
10. In addition to the above, patients who evaluated by the researchers are not eligible to participate in the clinical trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in estimated glomerular filtration rate;

Secondary Outcome Measures

Name	Time	Method
umber of rehospitalizations during the follow-up period;Quality of life;Change from baseline in TNF-a, IL-1ß, and IL-6;Change from baseline in urinary protein/creatinine ratio (PCR);the time and incidence of ESRD or a 50% decrease in eGFR;Change from baseline in creatinine and 24-hour urine protein;Change from baseline in hs-CRP;